Posted: March 18th, 2024

Evidence based research involving human subjects

Human Subjects

Assignment Prompt

This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants.

Evidence based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process. Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 3 “short” sentences for each question:

a. Historical background of human subjects’ protection?

b. Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated.

c. What steps will you take to minimize risks on human subjects?

d. What populations are considered vulnerable populations and why?

e. What are appropriate ways to recruit subjects?

f. How would you properly obtain consent?

g. What are the elements of a properly executed consent?

h. What committees are responsible for monitoring the protection of human subjects?

Historical Background and Protecting Human Subjects in Research

a. The historical background of human subjects’ protection stems from past abuses and unethical research practices that resulted in harm to participants. The Nuremberg Code of 1947 was one of the earliest guidelines establishing ethical principles like informed consent and minimizing risks after the unethical experiments by Nazi doctors during World War II. The Belmont Report of 1979 further outlined key ethical principles of respect for persons, beneficence, and justice that became the basis for regulating human subjects research.

b. One infamous historical incident of human subjects abuse was the Tuskegee Syphilis Study from 1932-1972, where researchers from the U.S. Public Health Service studied syphilis progression in Black men without informed consent or proper treatment, violating their rights to ethical medical care and autonomy. Hundreds of men suffered severe health problems and premature death due to this unethical study.

c. To minimize risks to human subjects, researchers must carefully design studies following ethical guidelines. This includes using appropriate recruitment, informed consent processes, minimizing risks through study procedures, having adverse event monitoring plans, maintaining participant confidentiality, and allowing voluntary withdrawal at any time. Risks and benefits must be thoroughly evaluated before the study begins.

d. Vulnerable populations requiring additional protections in research include children, prisoners, pregnant women, decisionally impaired individuals, and economically or educationally disadvantaged groups. They may have reduced autonomy, be susceptible to coercion, or face other potential vulnerabilities impacting their ability to protect their own interests. Careful consideration of risks, benefits, and consent processes is critical.

e. Appropriate recruitment methods preserve participants’ autonomy and volunteerism through measures like public advertisements, contacting potential participants directly while explaining the voluntary nature, and avoiding undue influence or coercion. Institutional review boards evaluate recruitment plans to ensure ethical practices.

f. Proper informed consent involves providing all relevant details about the research to participants in an easy-to-understand manner, ensuring comprehension, and obtaining their voluntary agreement to participate without coercion. The consent process should be an ongoing discussion throughout the study.

g. Key elements of proper consent include explaining the research purpose, risks, benefits, alternatives, ability to withdraw, privacy protections, contacts for questions, and an understandable consent document. Sufficient opportunity for participants to consider and ask questions must also be provided.

h. Institutional review boards (IRBs) are committees responsible for reviewing and monitoring human subjects research at institutions to ensure ethical standards and federal regulations are followed. Their oversight helps protect participants’ rights and welfare throughout studies.

References [Fictional placeholder references]

Dawson, A.J. (2018). Ethics in human subjects research. Journal of Research Ethics, 22(3), 145-167.

Lee, K., & Romero, F.P. (2020). Vulnerable populations in clinical trials. Annual Review of Public Health, 41, 525-543.

National Institutes of Health. (2023). Protecting human research participants online training. Retrieved from https://phrp.nihtraining.com

Richardson, H.S. (2015). Moral entanglements: The ancillary-care obligations of medical researchers. Oxford University Press.

Weijer, C., & Miller, P.B. (2021). Ethical foundations for robust human research protection. American Journal of Bioethics, 21(4), 16-28.

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Study Notes & Homework Samples: RES7002 Research Methods Empirical Research Project »NURS 335 Evidence Based Practice Nursing